FDA APPROVES ASTRAZENECA'S NEXIUM FOR STOMACH CONDITION

AstraZeneca announced that the FDA has approved a new indication for the company's proton pump inhibitor Nexium (esomeprazole magnesium) for the treatment of Zollinger-Ellison Syndrome. The drug is already indicated for the treatment of gastroesophageal reflux disease in adults and children ages 12 to 17.

Zollinger-Ellison Syndrome is a rare but serious chronic condition characterized by the development of tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach.

The new indication for Nexium is based on clinical trials in which 21 patients received one of several doses of Nexium, depending on their symptoms and the degree of their acid output. The 12-month, open-label trial demonstrated that Nexium effectively maintains basal acid output control in this patient population. The drug was well-tolerated throughout the trial.

Nexium is also approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as for healing erosive esophagitis. Additionally, the drug is indicated for reducing the risk of gastric ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug therapy.